The U.S. health regulator approved GW Pharmaceuticals Plc's epilepsy treatment on Monday, making it the first cannabis-based drug to win approval in the country and opening floodgates for more research into the medicinal properties of cannabis. United Kingdom -based GW Pharmaceuticals says the solution, taken by mouth, is made from a proprietary strain of cannabis created to maximize a therapeutic component while minimizing components that produce euphoria.
The oral solution contains cannabidiol, or CBD, a nonpsychoactive compound that has proved beneficial in reducing the catastrophic, potentially life-threatening seizures that accompany both conditions. Where is weed legal?
"The FDA prepares and transmits... a medical and scientific analysis of substances subject to scheduling, like CBD, and provides recommendations to the Drug Enforcement Administration (DEA) regarding controls under the [Controlled Substances Act]", the FDA stated, indicating that it will recommend that CBD be rescheduled but the act of shifting the substance's legality is ultimately in the DEA's hands.
Shlomo Shinnar, president of the American Epilepsy Society and a neurologist at Montefiore Medical Center in NY, has said the drug will be "a very valuable addition" to the limited options for treating severe childhood-onset epilepsy.
There are likely to be drug interactions, she said, but "that's not uncommon for antiepileptic medications", and she noted that this could affect the effectiveness of the medication.
This drug is a treatment option of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome. According to the New York Times, analysts expect Epidiolex to cost $2,500 to $5,000 a month. Carreno says that a leader drug like Epidiolex often paves the way for other less expensive-and untested-CBD products.
The approval of Epidiolex may help open the door to more CBD research, as it helps to lift one regulatory hurdle.
A government-regulated version of the oil will ease some doubts about the amount of CBD in the product, which can vary based on its origin, said Dr. Elaine Wirrell, director of the Mayo Clinic's child epilepsy program. The FDA has previously sent warning letters to companies that hyped their products as cancer or Alzheimer's fighters.
It's not clear how quickly the drug will be available for prescription.
Nine states plus Washington, D.C., have legalized medical marijuana, and the FDA said even more are considering it, particularly after it approved Epidolex.
Despite increasing acceptance, there is little rigorous research on the benefits and harms of marijuana. This treatment we have studied for the last five years.
Epidiolex was recommended for approval by an advisory committee in April, and the agency had until this week to make a decision.
As a result, Epidiolex's launch remains at the discretion of the DEA which must now evaluate the drug and consider reclassifying it as a substance that has medical properties, which would allow GW to begin selling it.
Gottlieb emphasized that the approval of Epidiolex does not have any implications for the approval of marijuana as a medicine more broadly, but the move is still widely seen by the industry as a significant step towards acceptance of the cannabis plant.
The European Medicines Agency is expected to rule on the therapy in early 2019.
Earlier, he accused Anadolu Agency of reporting votes from areas that favored Erdogan to undermine opposition morale. In uncharacteristically conciliatory remarks , Erdogan said Turkey had taught the world "a lesson in democracy".
The company said the shift will require additional investment and could take nine to 18 months to complete. Mr Trump said he was surprised the motorcycle maker had been "the first to wave the white flag".
They also searched a nearby river after it was noticed that a sniffer dog ran up to the river bank and just stopped there. Alex's body was identified by his father based upon the gold chain he was wearing, said the police.
It was the 38-year-old veteran's first appearance of the tournament and he has scored for Australia in the past three World Cups. It was Peru's first World Cup goal since Guillermo La Rosa scored in a 5-1 defeat by Poland at the 1982 finals in Spain.
Bagley never unseated Doncic, but by March Arizona's Deandre Ayton claimed that No. 1 prospect title (one he'd never relinquish). After that, it was a mostly straightforward draft with little fireworks, but plenty of national champion Villanova Wildcats.
And then things got pretty intense. "I have to get over it and move on, and that's my job", Fallon told the audience. I agree. 'Do whatever you want with my hair. "'You know the grind and you know me".
European Commission Vice President Jyrki Katainen (left) attends a meeting with China's Premier Li Keqiang in Beijing . China, the EU, Canada and Mexico have all responded with countermeasures to protectionist tariffs announced by Trump.
Want to check out all of the new features that Apple has added to iOS , the operating system for iPhones and iPads? This means those in the public Apple Beta Software Program can now install this test software on their devices .
For the traditionalists who criticized her pregnancy, she also had an updated news flash for them as well. It turns out that moment was at least partially for show, because the couple was already married.
Kane fires England to knockout stage
That is the scenario heading into Thursday's clash with Belgium, who would reportedly rather finish as runners-up. England completed 25 passes in the buildup, the most in any World Cup match since 1966, according to Opta.
Railroad unloading oil from cars after Iowa derailment
The spill reached the Rock River, which joins the Big Sioux River before merging into the Missouri River at Sioux City. A Conoco spokesman said that each tank auto could hold more than 25,000 gallons of oil (about 600 42-gallon barrels).
Australia’s Ben Simmons crowned NBA Rookie of the Year
The NBA has named Aussie star Ben Simmons the league's Rookie of the Year at the NBA Awards in Santa Monica, California. The 6-foot-10 point forward from Australia edged out Utah's Donovan Mitchell and Boston's Jayson Tatum for the honor.
FPJ's dream XI predictions for Denmark vs France
He said: "Obviously, if you told us that today we would have four points from two games then it wouldn't be too bad". However, even a defeat could send them into the last 16 depending on what is happening in the other match.
Ronnie Ortiz-Magro’s Ex Arrested for Domestic Battery
Ortiz-Magro, 32, who now lives in Las Vegas , and his ex-girlfriend, Jen Harley , welcomed a baby girl, Ariana Sky , on April 3. Their 2-month-old daughter, Ariana , was apparently in the auto with the troubled couple at the time of the incident.
Jimmy Fallon responds to President Trump's critical tweet
Fallon tweeted on Sunday that he'd made a donation to the refugee and immigration organization RAICES in the president's name. I didn't think that would be a compliment: "'He did the thing that we all wanted to do'". "It's insane .